AGILTRAC .035 PERIPHERAL DILATATION CATHETER

K022738 · Guidant Corp. · DQY · Sep 13, 2002 · Cardiovascular

Device Facts

• Record ID: K022738
• Device Name: AGILTRAC .035 PERIPHERAL DILATATION CATHETER
• Applicant: Guidant Corp.
• Product Code: DQY · Cardiovascular
• Decision Date: Sep 13, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AGILTRACTM .035 Peripheral Dilatation Catheter is indicated for the dilatation of stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, renal arteries) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Story

Over-the-wire percutaneous transluminal angioplasty (PTA) catheter; dual-lumen shaft design. Smaller lumen for balloon inflation with contrast medium; larger lumen for 0.035" guidewire advancement. Distal end features XCELON (nylon blend) balloon with two radiopaque markers for positioning. Distal shaft and balloon coated with Microglide (silicone-based) to reduce friction. Proximal end includes sidearm adaptor with luer-lock for inflation device connection. Used by physicians in clinical settings to dilate stenotic peripheral arteries or obstructive arteriovenous dialysis fistulae. Balloon expansion at specific pressures restores vessel patency, improving blood flow.

Clinical Evidence

Bench testing only. Safety and effectiveness demonstrated through in vitro bench tests and analyses.

Technological Characteristics

Dual-lumen catheter; XCELON (nylon blend) balloon; Microglide (silicone-based) coating. Radiopaque markers for positioning. Luer-lock proximal fitting. Sterilization and packaging equivalent to predicate. No software or electronic components.

Indications for Use

Indicated for patients requiring dilatation of stenoses in peripheral arteries (iliac, femoral, ilio-femoral, popliteal, renal) or treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• AGILTRAC .018 Peripheral Dilatation Catheter (K022738)

Submission Summary (Full Text)

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K022738

# SEP 1 3 2002

#### 510(k) SUMMARY

The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92

| Submitter's Name: | Guidant Corporation<br>Endovascular Solutions |
|-----------------------------|------------------------------------------------|
| Submitter's Address: | 1525 O'Brien Drive<br>Menlo Park, CA 94025 |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Nadine Sakakini |
| Date Prepared: | August 16, 2002 |
| Device Trade Name: | AGILTRACTM .035 Peripheral Dilatation Catheter |
| Device Common Name: | Percutaneous Transluminal Angioplasty Catheter |
| Device Classification Name: | DQY |
| Device Classification: | Class II |

### Summary of Substantial Equivalence:

The AGILTRACTM .035 Peripheral Dilatation Catheter is available with balloon diameters of 4.0-10.0 mm, with lengths of 20, 40 and 60 mm, 12.0 and 14.0 mm balloon diameters with lengths of 20 and 40 mm, 4.0-8.0 mm balloon diameters with a length of 80mm and 4.0-7.0 mm balloon diameters with a length of 100mm. The catheter lengths are 55 cm, 80 cm and 135 cm. The AGILTRACTM .035 Peripheral Dilatation Catheter is substantially equivalent to Guidant's AGILTRACTM . 018 Peripheral Dilatation Catheter consisting of balloon diameters of 4.0-12.0mm, balloon lengths of 20, 30, 40 and 60 mm with system lengths of 80cm and 135 cm. The AGILTRACTM .035 Peripheral Dilatation Catheter is substantially equivalent to the legally marketed comparison device with respect to design, materials, method of delivery and intended use.

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## Device Description:

The AGILTRAC™ . 035 Peripheral Dilatation Catheter is an over the wire catheter with an XCELON™ (nylon blend) balloon bonded at the distal end. The shaft is a dual lumen design. The smaller lumen provides for inflation of the balloon with contrast medium and the larger lumen permits use of a 0.035" guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The distal 20 cm of the catheter shaft and the entire length of the balloon are coated with Microglide®, a silicone based material used to reduce friction by providing a surface film over the catheter shaft.

The balloon, which has two (2) radiopaque markers to aid in positioning the balloon in the stenosis, is designed to provide an expandable segment of known diameter and length at specific pressures.

The proximal end of the catheter has a sidearm adaptor that provides access to the inflation lumen and guidewire lumen. It is designed with a luer-lock fitting for connection with an inflation device.

### Indications for Use:

The AGILTRACTM . 035 Peripheral Dilatation Catheter is intended:

- To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries); and
- . For the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

### Technological Characteristics:

Comparisons of the subject and predicate device show that technological characteristics such as materials, biocompatibility, mode of operation, performance properties, sterilization and packaging are substantially equivalent to the currently marketed predicate device, the AGILTRACTM . 018 Peripheral Dilatation Catheter.

### Performance Data:

The safety and effectiveness of the AGILTRACTM .035 Peripheral Dilatation Catheter has been demonstrated through data collected from in vitro bench tests and analyses.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with flowing lines connecting them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP 1 3 2002

Guidant Corporation c/o Ms. Nadine Sakakini Regulatory Affairs Associate 1525 O'Brian Drive Menlo Park, CA 94025

K022738 Re:

> Trade Name: AGILTRACTM .035 Peripheral Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DQY Dated: August 16, 2002 Received: August 19, 2002

Dear Ms. Sakakini:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 -- Ms. Nadine Sakakini

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

K. Deen Telle

am D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use Statement

| 510(k) Number (if known): | 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 |
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Device Name: AGILTRACTM .035 Peripheral Dilatation Catheter

Indications for Use:

The AGILTRACTM .035 Peripheral Dilatation Catheter is indicated for the dilatation of stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, renal arteries) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

Division of Cardiovascular & Respiratory Devices

510(k) Number